ABSTRACT ? Novel Approaches to Infant Screening for ASD in Pediatric Primary Care The overall goal of this project is to develop and validate novel tools to identify risk for autism spectrum disorder (ASD) in infants 6-12 months of age in a pediatric primary care setting. Research has confirmed that ASD is associated with changes in brain and behavior that are evident during infancy, and proof-of-concept studies suggest that early intervention during the infant period can improve early brain function and developmental outcomes. Moreover, early universal autism screening has been shown to reduce existing disparities based on socioeconomic status (SES) and ethnicity/race in access to early diagnosis and treatment. This project leverages ongoing work that is currently funded as part of the Duke NIH Autism Center of Excellence (ACE) Award (NICHD P50 HD093074; Dawson, Center Director), which is evaluating a novel digital phenotyping tool for early ASD risk assessment in toddler-age children in a pediatric primary care setting. Our novel screening tool, SenseToKnow, is based on active closed-loop sensing, where children are shown brief, developmentally-appropriate, dynamic stimuli on a smart tablet or smartphone, while the sensors in the same device capture information for automatic, objective quantification of several behavioral risk markers, based on patterns of attention, orienting, affect, vocalizations, and motor behavior. The proposed research will 1) evaluate a novel infant version of the app, SenseToKnow-Infant, in a large population of infants in the context of routine pediatric care, and 2) examine the utility of a multi- modal approach to risk assessment that combines information from SenseToKnow-I with information from infant and maternal electronic health records (EHRs). Using both direct digital behavioral measurement via SenseToKnow-I and data readily available in the EHR, we aim to develop and validate a multimodal ASD risk assessment algorithm for use in infants (6-12 months of age) that can be deployed in the general population.